Trial Setback For Gilead Sciences: Shuts Late-Stage Magrolimab/Azacitidine Combo Study In Type Of Blood Cancer

Gilead Sciences Inc GILD decided to discontinue the Phase 3 ENHANCE study in higher-risk myelodysplastic syndromes (MDS) due to futility based on a planned analysis. 

The Phase 3 study evaluated the combination of magrolimab plus azacitidine as first-line treatments for higher-risk myelodysplastic syndromes (HR-MDS). 

The study enrolled more than 500 patients randomized to receive magrolimab in combination with azacitidine or azacitidine monotherapy. 

The primary endpoints were complete response and overall survival.

In January 2022, The FDA placed a partial clinical hold on Gilead's studies evaluating the combination of magrolimab plus azacitidine.

Due to an apparent imbalance in investigator-reported suspected unexpected serious adverse reactions between study arms, the agency has taken action.

In April, the FDA lifted the partial clinical hold after reviewing the comprehensive safety data from each trial.

The company can resume enrollment in the U.S. with the magrolimab combo studies in MDS and acute myeloid leukemia (AML). 

Magrolimab is a potential first-in-class, anti-CD47 immunotherapy with a clinical development program spanning ten potential indications, including ongoing trials in solid tumors and two pivotal trials: ENHANCE-2 study in AML with TP53 mutations and ENHANCE-3 in first-line, unfit AML.

Gilead is working with study investigators on appropriate next steps for patients enrolled in the ENHANCE study. Data will be submitted for presentation at an upcoming medical meeting.

Price Action: GILD shares are down 1.77% at $79.21 during the premarket session on the last check Monday.